Molar Sodium Lactate Filling in Severe Meningeal Hemorrhage

Phase 3

Recruiting

• Conditions: Subarachnoid Hemorrhage, Aneurysmal
• Interventions: Drug: Molar Sodium Lactate; Drug: physiological serum

• Registration Number: NCT04141371
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

Subarachnoid hemorrhage by aneurysmal rupture is a serious condition associated with a high mortality rate. Among the complications presented by these patients, vasospasm is one of the main causes of secondary aggravation, in particular the appearance of delayed neurological deficits following the induced cerebral ischemia. Classically occurring between the 4th and 12th day, with a peak on D7, its prevention is currently often ineffective.

In recent years, many studies have shown that sodium lactate could be an interesting product for neuroprotection. In addition to an anti-osmotic effect that has been demonstrated by our team in the context of post-traumatic intracranial hypertension, a metabolic action has also been observed in periods of metabolic attacks induced by brain attacks. Recently, a vasodilatory action of sodium lactate has been observed from an experimental and clinical point of view.

The purpose of this work is to observe the effect of sodium lactate, compared to placebo, on cerebral hemodynamics measured by perfusion CT (Mean Transit Time MTT) in a population of patients with hemorrhage under the arachnoid.

This work is the preliminary work of a study that will investigate the potential preventive protective effect of sodium lactate on the incidence of vasospasm.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-10-25
• Study First Submitted QC: 2019-10-25
• Study First Posted: 2019-10-28
• Study Start: 2022-02-14
• Primary Completion: 2022-05-05
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-11
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Any patient over 18 years of age with severe meningeal hemorrhage defined by a WFNS≥3 score will be included in the study.
• Treated by endovascular embolization or surgically within 48 hours
• After obtaining the informed consent of the patient, or his relatives if he is not searchable (coma).
• Affiliation to a social security system
• After an adapted preliminary medical examination

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Exclusion Criteria

• Post-traumatic meningeal hemorrhage
• Management time >48h with respect to bleeding
• Known neurodegenerative pathology (Alzheimer's, Parkinson's, etc.), Creutzfeldt-Jacob disease
• Pregnant woman
• Decision not to treat
• Refusal to participate in the study
• Adult patient protected by law
• Person deprived of administrative or judicial freedom

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Molar Sodium Lactate	Molar Sodium Lactate	-
physiological serum	physiological serum	-

Primary Outcome Measures

Name	Time	Method
median transit time (MTT)	7 days	median transit time (MTT) in seconds, on the perfusion scanner on 6 regions of the brain between D0 and D7 of the product perfusion

Trial Locations

Locations (3)

Grenoble Hospital; 🇫🇷 Grenoble, France

Carole ICHAI; 🇫🇷 Nice, France

Marseille Hospital; 🇫🇷 Marseille, France